Impact of Prior Chemotherapy Use on the Efficacy of Everolimus in Patients With Advanced Pancreatic Neuroendocrine Tumors
Identifieur interne : 000277 ( Ncbi/Merge ); précédent : 000276; suivant : 000278Impact of Prior Chemotherapy Use on the Efficacy of Everolimus in Patients With Advanced Pancreatic Neuroendocrine Tumors
Auteurs : Catherine Lombard-Bohas ; James C. Yao ; Timothy Hobday ; Eric Van Cutsem ; Edward M. Wolin ; Ashok Panneerselvam ; Sotirios Stergiopoulos ; Manisha H. Shah ; Jaume Capdevila ; Rodney PommierSource :
- Pancreas [ 0885-3177 ] ; 2015.
Abstract
The aim of this study was to evaluate efficacy and safety of everolimus in patients with pancreatic neuroendocrine tumors (pNET) by prior chemotherapy use in the RAD001 in Advanced Neuroendocrine Tumors, Third Trial (RADIANT-3).
Patients with advanced, progressive, low- or intermediate-grade pNET were prospectively stratified by prior chemotherapy use and World Health Organization performance status and were randomly assigned (1:1) to everolimus 10 mg/d (n = 207) or placebo (n = 203).
Of the 410 patients, 204 (50%) were naive to chemotherapy (chemonaive). Baseline characteristics were similar for patients with or without prior chemotherapy. Everolimus significantly prolonged median progression-free survival regardless of prior chemotherapy use (prior chemotherapy: 11.0 vs 3.2 months; hazard ratio, 0.34; 95% confidence interval, 0.25–0.48;
As more treatment options become available, it is important to consider the goals of treatment and to identify patients who would potentially benefit from a specific therapy. Findings from this planned subgroup analysis suggest the potential for first-line use of everolimus in patients with advanced pNET.
Url:
DOI: 10.1097/MPA.0000000000000262
PubMed: 25479584
PubMed Central: 4327560
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Impact of Prior Chemotherapy Use on the Efficacy of Everolimus in Patients With Advanced Pancreatic Neuroendocrine Tumors</title>
<author><name sortKey="Lombard Bohas, Catherine" sort="Lombard Bohas, Catherine" uniqKey="Lombard Bohas C" first="Catherine" last="Lombard-Bohas">Catherine Lombard-Bohas</name>
<affiliation><nlm:aff id="aff1">From the *Department of Medical Oncology, Hôpital Edouard Herriot, Hospices Civils de Lyon, Lyon, France; †Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX; ‡Department of Oncology, Mayo Clinic College of Medicine, Rochester, MN; §Digestive Oncology, University Hospitals Gasthuisberg/Leuven, Leuven, Belgium; ∥Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, CA; ¶Department of Oncology Biometrics and Data, and #Department of Oncology, Novartis Pharmaceuticals Corporation, East Hanover, NJ; **Department of Medical Oncology, The Ohio State University, Columbus, OH; ††Department of Medical Oncology, Vall d’Hebron University Hospital, Barcelona, Spain; and ‡‡Division of Surgical Oncology, Oregon Health & Science University, Portland, OR.</nlm:aff>
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<author><name sortKey="Yao, James C" sort="Yao, James C" uniqKey="Yao J" first="James C." last="Yao">James C. Yao</name>
<affiliation><nlm:aff id="aff1">From the *Department of Medical Oncology, Hôpital Edouard Herriot, Hospices Civils de Lyon, Lyon, France; †Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX; ‡Department of Oncology, Mayo Clinic College of Medicine, Rochester, MN; §Digestive Oncology, University Hospitals Gasthuisberg/Leuven, Leuven, Belgium; ∥Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, CA; ¶Department of Oncology Biometrics and Data, and #Department of Oncology, Novartis Pharmaceuticals Corporation, East Hanover, NJ; **Department of Medical Oncology, The Ohio State University, Columbus, OH; ††Department of Medical Oncology, Vall d’Hebron University Hospital, Barcelona, Spain; and ‡‡Division of Surgical Oncology, Oregon Health & Science University, Portland, OR.</nlm:aff>
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<author><name sortKey="Hobday, Timothy" sort="Hobday, Timothy" uniqKey="Hobday T" first="Timothy" last="Hobday">Timothy Hobday</name>
<affiliation><nlm:aff id="aff1">From the *Department of Medical Oncology, Hôpital Edouard Herriot, Hospices Civils de Lyon, Lyon, France; †Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX; ‡Department of Oncology, Mayo Clinic College of Medicine, Rochester, MN; §Digestive Oncology, University Hospitals Gasthuisberg/Leuven, Leuven, Belgium; ∥Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, CA; ¶Department of Oncology Biometrics and Data, and #Department of Oncology, Novartis Pharmaceuticals Corporation, East Hanover, NJ; **Department of Medical Oncology, The Ohio State University, Columbus, OH; ††Department of Medical Oncology, Vall d’Hebron University Hospital, Barcelona, Spain; and ‡‡Division of Surgical Oncology, Oregon Health & Science University, Portland, OR.</nlm:aff>
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<author><name sortKey="Van Cutsem, Eric" sort="Van Cutsem, Eric" uniqKey="Van Cutsem E" first="Eric" last="Van Cutsem">Eric Van Cutsem</name>
<affiliation><nlm:aff id="aff1">From the *Department of Medical Oncology, Hôpital Edouard Herriot, Hospices Civils de Lyon, Lyon, France; †Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX; ‡Department of Oncology, Mayo Clinic College of Medicine, Rochester, MN; §Digestive Oncology, University Hospitals Gasthuisberg/Leuven, Leuven, Belgium; ∥Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, CA; ¶Department of Oncology Biometrics and Data, and #Department of Oncology, Novartis Pharmaceuticals Corporation, East Hanover, NJ; **Department of Medical Oncology, The Ohio State University, Columbus, OH; ††Department of Medical Oncology, Vall d’Hebron University Hospital, Barcelona, Spain; and ‡‡Division of Surgical Oncology, Oregon Health & Science University, Portland, OR.</nlm:aff>
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<author><name sortKey="Wolin, Edward M" sort="Wolin, Edward M" uniqKey="Wolin E" first="Edward M." last="Wolin">Edward M. Wolin</name>
<affiliation><nlm:aff id="aff1">From the *Department of Medical Oncology, Hôpital Edouard Herriot, Hospices Civils de Lyon, Lyon, France; †Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX; ‡Department of Oncology, Mayo Clinic College of Medicine, Rochester, MN; §Digestive Oncology, University Hospitals Gasthuisberg/Leuven, Leuven, Belgium; ∥Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, CA; ¶Department of Oncology Biometrics and Data, and #Department of Oncology, Novartis Pharmaceuticals Corporation, East Hanover, NJ; **Department of Medical Oncology, The Ohio State University, Columbus, OH; ††Department of Medical Oncology, Vall d’Hebron University Hospital, Barcelona, Spain; and ‡‡Division of Surgical Oncology, Oregon Health & Science University, Portland, OR.</nlm:aff>
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<author><name sortKey="Panneerselvam, Ashok" sort="Panneerselvam, Ashok" uniqKey="Panneerselvam A" first="Ashok" last="Panneerselvam">Ashok Panneerselvam</name>
<affiliation><nlm:aff id="aff1">From the *Department of Medical Oncology, Hôpital Edouard Herriot, Hospices Civils de Lyon, Lyon, France; †Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX; ‡Department of Oncology, Mayo Clinic College of Medicine, Rochester, MN; §Digestive Oncology, University Hospitals Gasthuisberg/Leuven, Leuven, Belgium; ∥Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, CA; ¶Department of Oncology Biometrics and Data, and #Department of Oncology, Novartis Pharmaceuticals Corporation, East Hanover, NJ; **Department of Medical Oncology, The Ohio State University, Columbus, OH; ††Department of Medical Oncology, Vall d’Hebron University Hospital, Barcelona, Spain; and ‡‡Division of Surgical Oncology, Oregon Health & Science University, Portland, OR.</nlm:aff>
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<author><name sortKey="Stergiopoulos, Sotirios" sort="Stergiopoulos, Sotirios" uniqKey="Stergiopoulos S" first="Sotirios" last="Stergiopoulos">Sotirios Stergiopoulos</name>
<affiliation><nlm:aff id="aff1">From the *Department of Medical Oncology, Hôpital Edouard Herriot, Hospices Civils de Lyon, Lyon, France; †Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX; ‡Department of Oncology, Mayo Clinic College of Medicine, Rochester, MN; §Digestive Oncology, University Hospitals Gasthuisberg/Leuven, Leuven, Belgium; ∥Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, CA; ¶Department of Oncology Biometrics and Data, and #Department of Oncology, Novartis Pharmaceuticals Corporation, East Hanover, NJ; **Department of Medical Oncology, The Ohio State University, Columbus, OH; ††Department of Medical Oncology, Vall d’Hebron University Hospital, Barcelona, Spain; and ‡‡Division of Surgical Oncology, Oregon Health & Science University, Portland, OR.</nlm:aff>
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<author><name sortKey="Shah, Manisha H" sort="Shah, Manisha H" uniqKey="Shah M" first="Manisha H." last="Shah">Manisha H. Shah</name>
<affiliation><nlm:aff id="aff1">From the *Department of Medical Oncology, Hôpital Edouard Herriot, Hospices Civils de Lyon, Lyon, France; †Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX; ‡Department of Oncology, Mayo Clinic College of Medicine, Rochester, MN; §Digestive Oncology, University Hospitals Gasthuisberg/Leuven, Leuven, Belgium; ∥Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, CA; ¶Department of Oncology Biometrics and Data, and #Department of Oncology, Novartis Pharmaceuticals Corporation, East Hanover, NJ; **Department of Medical Oncology, The Ohio State University, Columbus, OH; ††Department of Medical Oncology, Vall d’Hebron University Hospital, Barcelona, Spain; and ‡‡Division of Surgical Oncology, Oregon Health & Science University, Portland, OR.</nlm:aff>
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<author><name sortKey="Capdevila, Jaume" sort="Capdevila, Jaume" uniqKey="Capdevila J" first="Jaume" last="Capdevila">Jaume Capdevila</name>
<affiliation><nlm:aff id="aff1">From the *Department of Medical Oncology, Hôpital Edouard Herriot, Hospices Civils de Lyon, Lyon, France; †Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX; ‡Department of Oncology, Mayo Clinic College of Medicine, Rochester, MN; §Digestive Oncology, University Hospitals Gasthuisberg/Leuven, Leuven, Belgium; ∥Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, CA; ¶Department of Oncology Biometrics and Data, and #Department of Oncology, Novartis Pharmaceuticals Corporation, East Hanover, NJ; **Department of Medical Oncology, The Ohio State University, Columbus, OH; ††Department of Medical Oncology, Vall d’Hebron University Hospital, Barcelona, Spain; and ‡‡Division of Surgical Oncology, Oregon Health & Science University, Portland, OR.</nlm:aff>
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<author><name sortKey="Pommier, Rodney" sort="Pommier, Rodney" uniqKey="Pommier R" first="Rodney" last="Pommier">Rodney Pommier</name>
<affiliation><nlm:aff id="aff1">From the *Department of Medical Oncology, Hôpital Edouard Herriot, Hospices Civils de Lyon, Lyon, France; †Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX; ‡Department of Oncology, Mayo Clinic College of Medicine, Rochester, MN; §Digestive Oncology, University Hospitals Gasthuisberg/Leuven, Leuven, Belgium; ∥Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, CA; ¶Department of Oncology Biometrics and Data, and #Department of Oncology, Novartis Pharmaceuticals Corporation, East Hanover, NJ; **Department of Medical Oncology, The Ohio State University, Columbus, OH; ††Department of Medical Oncology, Vall d’Hebron University Hospital, Barcelona, Spain; and ‡‡Division of Surgical Oncology, Oregon Health & Science University, Portland, OR.</nlm:aff>
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Impact of Prior Chemotherapy Use on the Efficacy of Everolimus in Patients With Advanced Pancreatic Neuroendocrine Tumors</title>
<author><name sortKey="Lombard Bohas, Catherine" sort="Lombard Bohas, Catherine" uniqKey="Lombard Bohas C" first="Catherine" last="Lombard-Bohas">Catherine Lombard-Bohas</name>
<affiliation><nlm:aff id="aff1">From the *Department of Medical Oncology, Hôpital Edouard Herriot, Hospices Civils de Lyon, Lyon, France; †Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX; ‡Department of Oncology, Mayo Clinic College of Medicine, Rochester, MN; §Digestive Oncology, University Hospitals Gasthuisberg/Leuven, Leuven, Belgium; ∥Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, CA; ¶Department of Oncology Biometrics and Data, and #Department of Oncology, Novartis Pharmaceuticals Corporation, East Hanover, NJ; **Department of Medical Oncology, The Ohio State University, Columbus, OH; ††Department of Medical Oncology, Vall d’Hebron University Hospital, Barcelona, Spain; and ‡‡Division of Surgical Oncology, Oregon Health & Science University, Portland, OR.</nlm:aff>
<wicri:noCountry code="subfield">OR.</wicri:noCountry>
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<author><name sortKey="Yao, James C" sort="Yao, James C" uniqKey="Yao J" first="James C." last="Yao">James C. Yao</name>
<affiliation><nlm:aff id="aff1">From the *Department of Medical Oncology, Hôpital Edouard Herriot, Hospices Civils de Lyon, Lyon, France; †Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX; ‡Department of Oncology, Mayo Clinic College of Medicine, Rochester, MN; §Digestive Oncology, University Hospitals Gasthuisberg/Leuven, Leuven, Belgium; ∥Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, CA; ¶Department of Oncology Biometrics and Data, and #Department of Oncology, Novartis Pharmaceuticals Corporation, East Hanover, NJ; **Department of Medical Oncology, The Ohio State University, Columbus, OH; ††Department of Medical Oncology, Vall d’Hebron University Hospital, Barcelona, Spain; and ‡‡Division of Surgical Oncology, Oregon Health & Science University, Portland, OR.</nlm:aff>
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</affiliation>
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<author><name sortKey="Hobday, Timothy" sort="Hobday, Timothy" uniqKey="Hobday T" first="Timothy" last="Hobday">Timothy Hobday</name>
<affiliation><nlm:aff id="aff1">From the *Department of Medical Oncology, Hôpital Edouard Herriot, Hospices Civils de Lyon, Lyon, France; †Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX; ‡Department of Oncology, Mayo Clinic College of Medicine, Rochester, MN; §Digestive Oncology, University Hospitals Gasthuisberg/Leuven, Leuven, Belgium; ∥Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, CA; ¶Department of Oncology Biometrics and Data, and #Department of Oncology, Novartis Pharmaceuticals Corporation, East Hanover, NJ; **Department of Medical Oncology, The Ohio State University, Columbus, OH; ††Department of Medical Oncology, Vall d’Hebron University Hospital, Barcelona, Spain; and ‡‡Division of Surgical Oncology, Oregon Health & Science University, Portland, OR.</nlm:aff>
<wicri:noCountry code="subfield">OR.</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Van Cutsem, Eric" sort="Van Cutsem, Eric" uniqKey="Van Cutsem E" first="Eric" last="Van Cutsem">Eric Van Cutsem</name>
<affiliation><nlm:aff id="aff1">From the *Department of Medical Oncology, Hôpital Edouard Herriot, Hospices Civils de Lyon, Lyon, France; †Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX; ‡Department of Oncology, Mayo Clinic College of Medicine, Rochester, MN; §Digestive Oncology, University Hospitals Gasthuisberg/Leuven, Leuven, Belgium; ∥Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, CA; ¶Department of Oncology Biometrics and Data, and #Department of Oncology, Novartis Pharmaceuticals Corporation, East Hanover, NJ; **Department of Medical Oncology, The Ohio State University, Columbus, OH; ††Department of Medical Oncology, Vall d’Hebron University Hospital, Barcelona, Spain; and ‡‡Division of Surgical Oncology, Oregon Health & Science University, Portland, OR.</nlm:aff>
<wicri:noCountry code="subfield">OR.</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Wolin, Edward M" sort="Wolin, Edward M" uniqKey="Wolin E" first="Edward M." last="Wolin">Edward M. Wolin</name>
<affiliation><nlm:aff id="aff1">From the *Department of Medical Oncology, Hôpital Edouard Herriot, Hospices Civils de Lyon, Lyon, France; †Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX; ‡Department of Oncology, Mayo Clinic College of Medicine, Rochester, MN; §Digestive Oncology, University Hospitals Gasthuisberg/Leuven, Leuven, Belgium; ∥Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, CA; ¶Department of Oncology Biometrics and Data, and #Department of Oncology, Novartis Pharmaceuticals Corporation, East Hanover, NJ; **Department of Medical Oncology, The Ohio State University, Columbus, OH; ††Department of Medical Oncology, Vall d’Hebron University Hospital, Barcelona, Spain; and ‡‡Division of Surgical Oncology, Oregon Health & Science University, Portland, OR.</nlm:aff>
<wicri:noCountry code="subfield">OR.</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Panneerselvam, Ashok" sort="Panneerselvam, Ashok" uniqKey="Panneerselvam A" first="Ashok" last="Panneerselvam">Ashok Panneerselvam</name>
<affiliation><nlm:aff id="aff1">From the *Department of Medical Oncology, Hôpital Edouard Herriot, Hospices Civils de Lyon, Lyon, France; †Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX; ‡Department of Oncology, Mayo Clinic College of Medicine, Rochester, MN; §Digestive Oncology, University Hospitals Gasthuisberg/Leuven, Leuven, Belgium; ∥Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, CA; ¶Department of Oncology Biometrics and Data, and #Department of Oncology, Novartis Pharmaceuticals Corporation, East Hanover, NJ; **Department of Medical Oncology, The Ohio State University, Columbus, OH; ††Department of Medical Oncology, Vall d’Hebron University Hospital, Barcelona, Spain; and ‡‡Division of Surgical Oncology, Oregon Health & Science University, Portland, OR.</nlm:aff>
<wicri:noCountry code="subfield">OR.</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Stergiopoulos, Sotirios" sort="Stergiopoulos, Sotirios" uniqKey="Stergiopoulos S" first="Sotirios" last="Stergiopoulos">Sotirios Stergiopoulos</name>
<affiliation><nlm:aff id="aff1">From the *Department of Medical Oncology, Hôpital Edouard Herriot, Hospices Civils de Lyon, Lyon, France; †Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX; ‡Department of Oncology, Mayo Clinic College of Medicine, Rochester, MN; §Digestive Oncology, University Hospitals Gasthuisberg/Leuven, Leuven, Belgium; ∥Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, CA; ¶Department of Oncology Biometrics and Data, and #Department of Oncology, Novartis Pharmaceuticals Corporation, East Hanover, NJ; **Department of Medical Oncology, The Ohio State University, Columbus, OH; ††Department of Medical Oncology, Vall d’Hebron University Hospital, Barcelona, Spain; and ‡‡Division of Surgical Oncology, Oregon Health & Science University, Portland, OR.</nlm:aff>
<wicri:noCountry code="subfield">OR.</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Shah, Manisha H" sort="Shah, Manisha H" uniqKey="Shah M" first="Manisha H." last="Shah">Manisha H. Shah</name>
<affiliation><nlm:aff id="aff1">From the *Department of Medical Oncology, Hôpital Edouard Herriot, Hospices Civils de Lyon, Lyon, France; †Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX; ‡Department of Oncology, Mayo Clinic College of Medicine, Rochester, MN; §Digestive Oncology, University Hospitals Gasthuisberg/Leuven, Leuven, Belgium; ∥Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, CA; ¶Department of Oncology Biometrics and Data, and #Department of Oncology, Novartis Pharmaceuticals Corporation, East Hanover, NJ; **Department of Medical Oncology, The Ohio State University, Columbus, OH; ††Department of Medical Oncology, Vall d’Hebron University Hospital, Barcelona, Spain; and ‡‡Division of Surgical Oncology, Oregon Health & Science University, Portland, OR.</nlm:aff>
<wicri:noCountry code="subfield">OR.</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Capdevila, Jaume" sort="Capdevila, Jaume" uniqKey="Capdevila J" first="Jaume" last="Capdevila">Jaume Capdevila</name>
<affiliation><nlm:aff id="aff1">From the *Department of Medical Oncology, Hôpital Edouard Herriot, Hospices Civils de Lyon, Lyon, France; †Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX; ‡Department of Oncology, Mayo Clinic College of Medicine, Rochester, MN; §Digestive Oncology, University Hospitals Gasthuisberg/Leuven, Leuven, Belgium; ∥Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, CA; ¶Department of Oncology Biometrics and Data, and #Department of Oncology, Novartis Pharmaceuticals Corporation, East Hanover, NJ; **Department of Medical Oncology, The Ohio State University, Columbus, OH; ††Department of Medical Oncology, Vall d’Hebron University Hospital, Barcelona, Spain; and ‡‡Division of Surgical Oncology, Oregon Health & Science University, Portland, OR.</nlm:aff>
<wicri:noCountry code="subfield">OR.</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Pommier, Rodney" sort="Pommier, Rodney" uniqKey="Pommier R" first="Rodney" last="Pommier">Rodney Pommier</name>
<affiliation><nlm:aff id="aff1">From the *Department of Medical Oncology, Hôpital Edouard Herriot, Hospices Civils de Lyon, Lyon, France; †Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX; ‡Department of Oncology, Mayo Clinic College of Medicine, Rochester, MN; §Digestive Oncology, University Hospitals Gasthuisberg/Leuven, Leuven, Belgium; ∥Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, CA; ¶Department of Oncology Biometrics and Data, and #Department of Oncology, Novartis Pharmaceuticals Corporation, East Hanover, NJ; **Department of Medical Oncology, The Ohio State University, Columbus, OH; ††Department of Medical Oncology, Vall d’Hebron University Hospital, Barcelona, Spain; and ‡‡Division of Surgical Oncology, Oregon Health & Science University, Portland, OR.</nlm:aff>
<wicri:noCountry code="subfield">OR.</wicri:noCountry>
</affiliation>
</author>
</analytic>
<series><title level="j">Pancreas</title>
<idno type="ISSN">0885-3177</idno>
<idno type="eISSN">1536-4828</idno>
<imprint><date when="2015">2015</date>
</imprint>
</series>
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<profileDesc><textClass></textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en"><sec><title>Objective</title>
<p>The aim of this study was to evaluate efficacy and safety of everolimus in patients with pancreatic neuroendocrine tumors (pNET) by prior chemotherapy use in the RAD001 in Advanced Neuroendocrine Tumors, Third Trial (RADIANT-3).</p>
</sec>
<sec><title>Methods</title>
<p>Patients with advanced, progressive, low- or intermediate-grade pNET were prospectively stratified by prior chemotherapy use and World Health Organization performance status and were randomly assigned (1:1) to everolimus 10 mg/d (n = 207) or placebo (n = 203).</p>
</sec>
<sec><title>Results</title>
<p>Of the 410 patients, 204 (50%) were naive to chemotherapy (chemonaive). Baseline characteristics were similar for patients with or without prior chemotherapy. Everolimus significantly prolonged median progression-free survival regardless of prior chemotherapy use (prior chemotherapy: 11.0 vs 3.2 months; hazard ratio, 0.34; 95% confidence interval, 0.25–0.48; <italic>P</italic>
< 0.0001) (chemonaive: 11.4 vs 5.4 months; hazard ratio, 0.42; 95% confidence interval, 0.29–0.60; <italic>P</italic>
< 0.0001). Stable disease was the best overall response in 73% of everolimus-treated patients (151/207). The most common drug-related adverse events included stomatitis (60%–69%), rash (47%–50%), and diarrhea (34%).</p>
</sec>
<sec><title>Conclusions</title>
<p>As more treatment options become available, it is important to consider the goals of treatment and to identify patients who would potentially benefit from a specific therapy. Findings from this planned subgroup analysis suggest the potential for first-line use of everolimus in patients with advanced pNET.</p>
</sec>
</div>
</front>
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</author>
<author><name sortKey="Hassan, M" uniqKey="Hassan M">M Hassan</name>
</author>
<author><name sortKey="Phan, A" uniqKey="Phan A">A Phan</name>
</author>
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<biblStruct><analytic><author><name sortKey="Phan, At" uniqKey="Phan A">AT Phan</name>
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<author><name sortKey="Yao, Jc" uniqKey="Yao J">JC Yao</name>
</author>
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<biblStruct><analytic><author><name sortKey="Halfdanarson, Tr" uniqKey="Halfdanarson T">TR Halfdanarson</name>
</author>
<author><name sortKey="Rabe, Kg" uniqKey="Rabe K">KG Rabe</name>
</author>
<author><name sortKey="Rubin, J" uniqKey="Rubin J">J Rubin</name>
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<biblStruct><analytic><author><name sortKey="Yao, Jc" uniqKey="Yao J">JC Yao</name>
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<author><name sortKey="Eisner, Mp" uniqKey="Eisner M">MP Eisner</name>
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<author><name sortKey="Leary, C" uniqKey="Leary C">C Leary</name>
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</TEI>
<pmc article-type="research-article"><pmc-dir>properties open_access</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-ta">Pancreas</journal-id>
<journal-id journal-id-type="iso-abbrev">Pancreas</journal-id>
<journal-id journal-id-type="publisher-id">MPA</journal-id>
<journal-title-group><journal-title>Pancreas</journal-title>
</journal-title-group>
<issn pub-type="ppub">0885-3177</issn>
<issn pub-type="epub">1536-4828</issn>
<publisher><publisher-name>Lippincott Williams & Wilkins</publisher-name>
</publisher>
</journal-meta>
<article-meta><article-id pub-id-type="pmid">25479584</article-id>
<article-id pub-id-type="pmc">4327560</article-id>
<article-id pub-id-type="publisher-id">MPA14311</article-id>
<article-id pub-id-type="doi">10.1097/MPA.0000000000000262</article-id>
<article-id pub-id-type="art-access-id">00002</article-id>
<article-categories><subj-group subj-group-type="heading"><subject>Original Articles</subject>
</subj-group>
</article-categories>
<title-group><article-title>Impact of Prior Chemotherapy Use on the Efficacy of Everolimus in Patients With Advanced Pancreatic Neuroendocrine Tumors</article-title>
<subtitle>A Subgroup Analysis of the Phase III RADIANT-3 Trial</subtitle>
</title-group>
<contrib-group><contrib contrib-type="author"><name><surname>Lombard-Bohas</surname>
<given-names>Catherine</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff1">*</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Yao</surname>
<given-names>James C.</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff1">†</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Hobday</surname>
<given-names>Timothy</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff1">‡</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Van Cutsem</surname>
<given-names>Eric</given-names>
</name>
<degrees>MD, PhD</degrees>
<xref ref-type="aff" rid="aff1">§</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Wolin</surname>
<given-names>Edward M.</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff1">∥</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Panneerselvam</surname>
<given-names>Ashok</given-names>
</name>
<degrees>PhD</degrees>
<xref ref-type="aff" rid="aff1">¶</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Stergiopoulos</surname>
<given-names>Sotirios</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff1">#</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Shah</surname>
<given-names>Manisha H.</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff1">**</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Capdevila</surname>
<given-names>Jaume</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff1">††</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Pommier</surname>
<given-names>Rodney</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff1">‡‡</xref>
</contrib>
</contrib-group>
<aff id="aff1">From the *Department of Medical Oncology, Hôpital Edouard Herriot, Hospices Civils de Lyon, Lyon, France; †Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX; ‡Department of Oncology, Mayo Clinic College of Medicine, Rochester, MN; §Digestive Oncology, University Hospitals Gasthuisberg/Leuven, Leuven, Belgium; ∥Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, CA; ¶Department of Oncology Biometrics and Data, and #Department of Oncology, Novartis Pharmaceuticals Corporation, East Hanover, NJ; **Department of Medical Oncology, The Ohio State University, Columbus, OH; ††Department of Medical Oncology, Vall d’Hebron University Hospital, Barcelona, Spain; and ‡‡Division of Surgical Oncology, Oregon Health & Science University, Portland, OR.</aff>
<author-notes><corresp id="cor1">Reprints: Rodney Pommier, MD, Division of Surgical Oncology, Oregon Health & Science University, Mail Code L619, Portland, OR 97239 (e-mail: <email>pommierr@ohsu.edu</email>
).</corresp>
</author-notes>
<pub-date pub-type="ppub"><month>3</month>
<year>2015</year>
</pub-date>
<pub-date pub-type="epub"><day>12</day>
<month>2</month>
<year>2015</year>
</pub-date>
<volume>44</volume>
<issue>2</issue>
<fpage>181</fpage>
<lpage>189</lpage>
<history><date date-type="received"><day>12</day>
<month>5</month>
<year>2014</year>
</date>
<date date-type="accepted"><day>14</day>
<month>8</month>
<year>2014</year>
</date>
</history>
<permissions><copyright-statement>Copyright © 2014 Wolters Kluwer Health, Inc. All rights reserved.</copyright-statement>
<copyright-year>2014</copyright-year>
<copyright-holder>Wolters Kluwer Health, Inc. All rights reserved.</copyright-holder>
<license><license-p>This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License, where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially.</license-p>
</license>
</permissions>
<self-uri xlink:type="simple" xlink:href="mpa-44-181.pdf"></self-uri>
<abstract><sec><title>Objective</title>
<p>The aim of this study was to evaluate efficacy and safety of everolimus in patients with pancreatic neuroendocrine tumors (pNET) by prior chemotherapy use in the RAD001 in Advanced Neuroendocrine Tumors, Third Trial (RADIANT-3).</p>
</sec>
<sec><title>Methods</title>
<p>Patients with advanced, progressive, low- or intermediate-grade pNET were prospectively stratified by prior chemotherapy use and World Health Organization performance status and were randomly assigned (1:1) to everolimus 10 mg/d (n = 207) or placebo (n = 203).</p>
</sec>
<sec><title>Results</title>
<p>Of the 410 patients, 204 (50%) were naive to chemotherapy (chemonaive). Baseline characteristics were similar for patients with or without prior chemotherapy. Everolimus significantly prolonged median progression-free survival regardless of prior chemotherapy use (prior chemotherapy: 11.0 vs 3.2 months; hazard ratio, 0.34; 95% confidence interval, 0.25–0.48; <italic>P</italic>
< 0.0001) (chemonaive: 11.4 vs 5.4 months; hazard ratio, 0.42; 95% confidence interval, 0.29–0.60; <italic>P</italic>
< 0.0001). Stable disease was the best overall response in 73% of everolimus-treated patients (151/207). The most common drug-related adverse events included stomatitis (60%–69%), rash (47%–50%), and diarrhea (34%).</p>
</sec>
<sec><title>Conclusions</title>
<p>As more treatment options become available, it is important to consider the goals of treatment and to identify patients who would potentially benefit from a specific therapy. Findings from this planned subgroup analysis suggest the potential for first-line use of everolimus in patients with advanced pNET.</p>
</sec>
</abstract>
<kwd-group><title>Key Words/Abbreviations</title>
<kwd>chemotherapy</kwd>
<kwd>everolimus</kwd>
<kwd>first-line therapy</kwd>
<kwd>mammalian target of rapamycin inhibition</kwd>
<kwd>AE - adverse event</kwd>
<kwd>CI - confidence interval</kwd>
<kwd>HR - hazard ratio</kwd>
<kwd>NET - neuroendocrine tumors</kwd>
<kwd>PFS - progression-free survival</kwd>
<kwd>pNET - pancreatic neuroendocrine tumors</kwd>
<kwd>RADIANT - RAD001 in Advanced Neuroendocrine Tumors</kwd>
<kwd>RECIST - Response Evaluation Criteria in Solid Tumors</kwd>
<kwd>SSA - somatostatin analogue</kwd>
<kwd>WHO - World Health Organization</kwd>
</kwd-group>
<custom-meta-group><custom-meta><meta-name>OPEN-ACCESS</meta-name>
<meta-value>TRUE</meta-value>
</custom-meta>
</custom-meta-group>
</article-meta>
</front>
</pmc>
<affiliations><list></list>
<tree><noCountry><name sortKey="Capdevila, Jaume" sort="Capdevila, Jaume" uniqKey="Capdevila J" first="Jaume" last="Capdevila">Jaume Capdevila</name>
<name sortKey="Hobday, Timothy" sort="Hobday, Timothy" uniqKey="Hobday T" first="Timothy" last="Hobday">Timothy Hobday</name>
<name sortKey="Lombard Bohas, Catherine" sort="Lombard Bohas, Catherine" uniqKey="Lombard Bohas C" first="Catherine" last="Lombard-Bohas">Catherine Lombard-Bohas</name>
<name sortKey="Panneerselvam, Ashok" sort="Panneerselvam, Ashok" uniqKey="Panneerselvam A" first="Ashok" last="Panneerselvam">Ashok Panneerselvam</name>
<name sortKey="Pommier, Rodney" sort="Pommier, Rodney" uniqKey="Pommier R" first="Rodney" last="Pommier">Rodney Pommier</name>
<name sortKey="Shah, Manisha H" sort="Shah, Manisha H" uniqKey="Shah M" first="Manisha H." last="Shah">Manisha H. Shah</name>
<name sortKey="Stergiopoulos, Sotirios" sort="Stergiopoulos, Sotirios" uniqKey="Stergiopoulos S" first="Sotirios" last="Stergiopoulos">Sotirios Stergiopoulos</name>
<name sortKey="Van Cutsem, Eric" sort="Van Cutsem, Eric" uniqKey="Van Cutsem E" first="Eric" last="Van Cutsem">Eric Van Cutsem</name>
<name sortKey="Wolin, Edward M" sort="Wolin, Edward M" uniqKey="Wolin E" first="Edward M." last="Wolin">Edward M. Wolin</name>
<name sortKey="Yao, James C" sort="Yao, James C" uniqKey="Yao J" first="James C." last="Yao">James C. Yao</name>
</noCountry>
</tree>
</affiliations>
</record>
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